A consortium of hemp and vape companies has sued Kentucky's newly approved PMTA registry statute in state court. Beginning on January 1, 2025, the legislation will prohibit the sale of the majority of vaping products that have not been approved for marketing by the FDA, are under FDA review, or are pending an appeal before the FDA or a court.
Four vaping firms, the Kentucky Smoke Free Association, and the Kentucky Hemp Association filed the complaint in Franklin Circuit Court on April 12. They are requesting that the register statute be ruled illegal and that the state be barred from executing the law via both interim and permanent injunctive relief.
The petitioners claim that the definition of vapor products in the law would now apply to legally available hemp-based and marijuana-based vaping products that are not subject to FDA regulation, in violation of the Kentucky Constitution's prohibition against applying laws to more than one subject.
No-nicotine vaping products, such as nicotine-free or nicotine analog vapes, CBD vapes, and other hemp-based cannabinoid vaping products, are not subject to FDA regulation and cannot apply for or be approved through the premarket tobacco application (PMTA) pathway. Because of this, they cannot be considered lawful items under the PMTA registration statute of Kentucky.
Attorney Greg Troutman told the Kentucky Lantern, "Unless the [hemp or marijuana] producers are making a therapeutic claim—that is, they're intended to cure, treat, mitigate disease—they're not subject to an FDA regulatory process." "How then can market authorization in Kentucky be contingent upon following a procedure that doesn't exist?"
Troutman is the attorney for the other petitioners who are suing the state, including the Kentucky Smoke Free Association. He has defended other vaping-related companies in court on many occasions.
On March 28, the Kentucky General Assembly's two chambers approved the legislation that established the state's PMTA registry statute. On April 5, Governor Andy Beshear signed House Bill 11 into law.
Big Tobacco firms, particularly Altria Group, the company that makes Marlboro cigarettes, have designed and advocated for identical PMTA registry legislation, which have been approved by several other states or are now being considered.
